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VASCU-GUARD vascular patches with the new packaging have been available at the Houston Methodist Hospital since January 2023. This study is a retrospective chart review, aiming to compare the performance of Baxter VASCU-GUARD vascular patches implemented during carotid endarterectomies (CEA) prior to January 2023 and after January 2023. This study is one of a kind, as no other comparative retrospective chart review on the performance of VASCU-GUARD vascular patches from the old and new packaging has been published yet.
The project will contribute to the scientific knowledge about long-term outcomes associated with the use of patch material during endarterectomies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches | Follow-up ultrasound assessment available |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid endarterectomy (CEA) | Procedure | carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound evaluation of Baxter VASCU-GUARD vascular patches | Retrospective review of ultrasound recordings and ultrasound reports at one-month, 3-months, 6-months and 1-year follow-up after endarterectomy - if available, to evaluate patch patency, morphology, integrity, complications, and blood flow dynamics | 1/1/2023 - 4/30/2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications assessment | Analyze complications linked with Baxter Vascular Patches (VASCU-GUARD), including but not limited to thrombosis, stroke, dissection, restenosis, infection, fluid collection, pseudoaneurysm formation, fraying or irregularities in patch material. | 1/1/2023 - 4/30/2024 |
| Correlation with Clinical Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
• No postoperative ultrasound assessment is available.
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Patients undergoing carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches in all campuses of the Houston Methodist Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
Only study findings to be shared
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2024 | Jun 23, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Recognize correlations between ultrasound findings and clinical outcomes. This correlation will complement the understanding of how ultrasound monitoring can predict and influence patient prognosis. |
| 1/1/2023 - 4/30/2024 |